Collaborative Innovation in CDMOs: Dave Miller, PhD, on Early Engagement, IP Strategy, and Advanced Formulation

*full transcript below

In part 1 of our 5-part interview series on the current CDMO landscape, Dave Miller, PhD, chief scientific officer at AustinPx, emphasizes that the role of contract development and manufacturing organizations (CDMOs) is evolving beyond traditional, transactional service models toward deeper, collaborative partnerships. Miller describes this shift as “true co-development,” where innovation and scientific engagement form the foundation of client relationships. Central to the company’s approach is the application of novel technologies, such as its KinetiSol platform, to solve complex formulation challenges through tailored, science-driven solutions.

Miller notes that differentiation in today’s CDMO landscape hinges on high-touch, high-science engagement, intellectual property (IP) protection, and regulatory expertise. Drawing from AustinPx’s history as a former sponsor company, the team leverages extensive experience with the FDA and international regulatory bodies to guide clients in both domestic and global markets. IP retention, including overlooked compositional IP for drug products, is a priority.

The company increasingly engages with partners earlier in the molecule’s lifecycle—often shortly after candidate nomination—to ensure formulation strategies align with clinical and regulatory objectives. This early involvement supports smoother transitions from preclinical to clinical phases and fosters product designs with a clear line of sight toward commercialization.

According to Miller, the future of the CDMO sector lies in “collaborative innovation” that spans the entire spectrum of development, from early-stage design to market readiness. By operating as an extension of the sponsor’s own development team, AustinPx aims to provide customized, end-to-end solutions that address both immediate formulation needs and the long-term protection and differentiation of the therapeutic asset.

Be on the lookout for parts 2-5 to drop in the coming days!

About the Interviewee

Dr. Miller brings over two decades of pharmaceutical development experience and has spent his career investigating ways to improve the bioavailability of poorly soluble molecules. As CSO of AustinPx, Dr. Miller leads the pharmaceutics and analytical development teams and oversees the application of the KinetiSol Technology. Prior to his current position, Dr. Miller served as Vice President of Research and Development at DisperSol Technologies and Senior Principal Scientist at Hoffmann-La Roche. Dr. Miller specializes in formulation and processing technologies for improving oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through all stages of development from early discovery to line extension. Dr. Miller is a co-inventor of the pharmaceutical applications of the KinetiSol technology and continues to be a key innovative driver for application and expansion of the platform. He has published over 40 research articles in peer-reviewed journals, authored 8 book chapters, and is co-editor of the First, Second, and Third Editions of the textbook, Formulating Poorly Water-Soluble Drugs. He is a co-inventor on numerous granted and pending patents worldwide. Dr. Miller holds a BS in Chemical Engineering and a PhD in Pharmaceutics from the University of Texas at Austin.

Transcript

I think from our experience and what we are dealing with, it's much more about partnerships these days than sort of transactional services. True co-development. And at the heart of that is sort of the novel platforms. You know, we have our KinetiSol platform that really is a driving force behind, you know, how we're partnering and developing products with our clients, but also high science, high touch.

You know, we're dealing with very complex formulation problems, and we offer novel solutions and novel insights. So I think it really comes down to just offering differentiating technologies, really focusing on partnering at the scientific level as opposed to just providing commodity services aimed at, you know, providing deliverables on time.

Also, with respect to ex-US partnerships, our clients also still value what they consider IP retention and trustworthiness, not just with respect to intellectual property, but also in regulatory settings as well. We have a long history as a company; in our prior incarnation, we were a sponsor company ourselves, developing our own pipeline of products and clinical development. So we have a long history of dealing with the FDA and other regulatory agencies outside of the United States. So that's certainly helpful for sponsors that are considering their options both domestic and abroad, as to who to select.

And going forward, it's all about differentiation and trustworthiness. And I think that's where we're really succeeding and as offering tailored solutions as well. Not just taking a molecule and putting it into some rigid framework, decision tree-type project progression, but rather, treating each molecule and each problem as unique and developing customized solutions.

So I think that's how we're at AustinPx differentiating ourselves from, from partners abroad, as well as domestically. I think we've seen sort of a paradigm shift towards much earlier engagement in the development and path of a molecule, interacting with us on the front end, shortly after even candidate nomination, toxicology studies, designing formulations, not just for clinic, but also to successfully transfer a molecule from preclinical into clinical development. So really early engagement. Establishing a CDMO partner who's going to be there as a co-developer, you know, the whole way through the process. So having capabilities that span the full spectrum of product development has been key for us. Um, 'cause we feel like the future in the CDMO space is collaborative innovation, and starting from the beginning in planning the development with the partner with all phases in mind and with the full lifecycle of the product in mind. So again, thinking about formulation insights, you know, that are tailored towards the exact phase of development that the molecule’s in now, but also with line of sight to the next step, aligning that with clinical strategy and regulatory positioning.

Also, again, talking about IP, I think compositional IP for drug products has been overlooked. I think a lot of companies focus primarily on the IP around the molecule as being what ultimately protects the asset. But we've kind of developed our approach, again, stemming from our own history as a sponsor company where the drug product, the composition of matter around the drug product, that IP is what really was protecting the asset.

So, we build that into our programs as well, where we're designing delivery systems specific for that molecule, solving simultaneous problems by tailoring the composition. And then in doing so, those problems… and providing the most robust, and high-performing dosage form, we sort of naturally generate novel composition matter IP and we're looking at that from day one.

In collaboration partners, even though it's years out, we're thinking about the full lifecycle of the molecule and protection of the asset on commercialization. So, that's where I think CDMOs… again, going back to just not just offering transactional services and checking the basic boxes of providing deliverables on a given timeline. It's more of an extension of the sponsor's development team and true collaborative innovation co-development. I think that's the expectation now. That's what we're doing.